Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02695069 |
| Other study ID # |
MCHHFoshan-1601 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
February 22, 2016 |
| Last updated |
November 9, 2017 |
| Start date |
January 2016 |
| Est. completion date |
April 2017 |
Study information
| Verified date |
November 2017 |
| Source |
Maternal and Child Health Hospital of Foshan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to assess the efficacy of random placenta margin incision for
hemorrhage control during cesarean section of complete placenta previa pregnancies.
Description:
Placenta previa is used to describe a placenta that is implanted over or very near the
internal cervical os and the complete placenta previa is defined that the internal os is
covered completely by placenta. This obstetric complication is associated with high risks for
maternal hemorrhage and emergency peripartum hysterectomy can be the only effective action to
take, although it carries many morbidities for the women especially those with low parity.
Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still
one of the important causes of maternal mortality. The only safe and appropriate mode of
delivery for placenta previa is by cesarean delivery. In the absence of accreta, this can
usually be accomplished using a lower segment uterine incision. Because of cutting through
the placenta, it is often associated with increased maternal bleeding. In addition, the
umbilical cord will be also excessive blood loss when the placenta is transected.
Theoretically, random placenta margin incision can effectively avoid the damage of the
placenta and reduce the maternal blood loss.
The investigators conduct a prospective study to assess the efficacy of random placenta
margin incision for hemorrhage control during cesarean section of complete placenta previa
pregnancies at Department of Obstetrics, Southern Medical University Affiliated Maternal and
Child Health Hospital of Foshan, since January 2016 till December 2016, after approval of the
study protocol by the Local Ethical Committee.
All participants have complete placenta previa and provide written informed consent to
undergo any procedure necessary as an attempt to avoid hysterectomy. And they also provide
written informed consent to undergo hysterectomy if all measures attempted to preserve the
uterus fail.
To precisely determine the placental location and the edge of the placenta, preoperative
ultrasonography is used in determining the optimal place for the uterine incision. The
investigator performed all cesarean deliveries and assisted by the second investigator. The
parietal peritoneum is opened by sharp dissection and blunt expansion, if necessary, high
above the bladder, a bladder flap is made and the bladder is retracted. A random hysterotomy
incision is done in the placenta margin. It is expanded on both sides using scissors,
stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by
searching manually for a plane of cleavage between the placenta and the uterus after delivery
of the fetus. In addition to uterotonics, measures such as "oversewing" of the placental bed,
intrauterine balloon tamponade, and B-Lynch or other compression sutures are also used
depending on different circumstances.
